Kornimate/medical-research-clean huggingface dataset:
obstructive sleep apnea and telomere length

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is a highly prevalent and morbid sleep disorder. among the factors associated with its pathophysiology, the role of intermittent hypoxia stands out, contributing to the development of oxidative stress and inflammation. it is known that cumulative levels of these factors negatively influence the final portion of the dna, known as telomere. in this sense, the investigators hypothesize that osa is capable of accelerating aging process through telomere shortening mediated by inflammatory and oxidative markers. thus, the aim of this study is to investigate the effect of osa and its treatment with cpap on the variation of telomere length and their associated mechanisms. for this, a randomized, double-blind, sham-controlled clinical study with 6 months duration will be conducted. we will recruit male participants with osa diagnosis (apnea-hypopnea indexe15/hour), aged between 35-65 years and body mass index\<35 kg/m2, which will be randomized to use cpap or sham-cpap for 6 months. participants will visit the laboratory 7 times (baseline and after 1, 2, 3, 4, 5 and 6 months) and will be submitted to clinical and otorhinolaryngological evaluation, sleep questionnaires, polysomnography and blood collection for dna and extraction and measurement of telomere length, as well as the expression of telomerase and oxidative and inflammatory markers (adma, homocysteine, cysteine, tbars, 8-oxodg, tnf-a, il-6 and il-10). this project aims to contribute to the elucidation of the effect of osa on telomere length maintenance, as well as the adjacent mechanisms to this relationship.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of less than 35kg/m2 * age between 35 and 65 years * diagnosed by laboratory polysomnography with moderate to severe osa (apnea-hypopnea index, ahi≥20 events/hour of sleep) exclusion criteria: * illiteracy * participants with more than 50% of the respiratory events obtained in the polysomnography exam being central apneas * participants with central ahi\>5 events/hour of sleep * participants with sleepiness, measured by the epworth sleepiness scale≥14 * participants with severe otorhinolaryngological diseases that preclude the use of cpap (severe nasal septum deviation, severe nasal turbinate hypertrophy, marked palatine and/or adenoid hypertrophy) * abuse of alcohol or chronic use of psychoactive drugs * participants with decompensated clinical, neurological or psychiatric illness * participants with other sleep disorders; participants who had already undergone previous osa treatments

Keywords: sleep telomere cpap
efficacy study of thymosin alpha1 & pegylated interferon-alpha2a to treat chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis b.

thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis b. it is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. we hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration. in detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.

Eligibility criteria:
inclusion criteria: * hbsag positive and anti-hbs negative for more than 6 months * hbeag positive * hbv dna titer more than 100,000 iu/ml * serum alt more than upper normal limit value, but no more than 10 times upper normal limit value exclusion criteria: * the history of antiviral therapy for chronic hepatitis b within the recent 6 months * hav igm ab + and/or hcv ab + and/or hdv ab and/or hiv ab + * the sign of decompensated liver disease * the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease * pregnant or lactating woman * neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3 * serum creatinine more than 1.5 times upper normal limit value * the sign of alcoholic or drug addiction within the recent 1 year * the history of psychotic disorder especially like depression * immunologically mediated disease * the history of esophageal varix * the history of severe heart disease or respiratory disease * the history of severe epilepsy or current use of antiepileptic drug * the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20% * the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid * the history of major organ transplantation * the history of medically uncontrolled thyroid disease * the history or sign of severe retinopathy

Keywords: chronic hepatitis b, pegylated interferon, thymosin alpha
monosialoganglioside in acute ischemic stroke: a randomized, blinded and multicenter confirmatory study

Conditions: Acute Ischemic Stroke

Summary: a multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of gm1 injection in the treatment of patients with acute ischemic stroke. it is estimated that 1706 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio. normally, the duration of this study is approximately 90 days. treatment was continued for 12\~14 days, and follow-up was conducted until the 90th day from the first dose. the trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase. screening/baseline period: after the subjects sign the informed consent form, they enter the screening/baseline period for screening examination. treatment period: qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 12\~14 days (12\~14 times) with gm1 injection and placebo respectively. during the treatment period, relevant examinations and evaluations required by the protocol will be carried out. follow-up period: subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.


Eligibility criteria:
inclusion criteria: * age: 18-80 years old； * patients with anterior circulation cerebral infarction; first stroke onset or past stroke without obvious neurological deficit (mrs score≤1)； * within 24 hours of onset； * 7 ≤nihss score ≤ 20； * signed informed consent. exclusion criteria: * patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as tay-sachs disease and retinal degeneration); * hemorrhagic stroke; * disturbance of consciousness (nihss1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases; * planed endovascular treatment; * uncontrolled hypertension: systolic pressure ≥200 mmhg or diastolic pressure ≥110 mmhg; * bleeding tendency (except for thrombolysis) or severe bleeding within 3 months; * patients with malignant tumor or serious diseases; * along with epilepsy, arthritis and other disease, which have effect on neurological assessment; * history of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (guillain barre syndrome); * unable or unwilling to cooperate due to mental diseases; * abnormal liver and renal function: alt, ast \> 2 times of the upper limit of normal value, or cr \> 1.5 times of the upper limit of normal value； * hypersensitivity to monosialoganglioside and excipients of test drug; * history of drug abuse； * pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period; * participating in other clinical trials within 3 months; * other conditions which are unsuitable for this trial assessed by researcher.
glyburide and metformin for gestational diabetes mellitus (gdm)

Conditions: Gestational Diabetes Mellitus

Summary: this is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.

gestational diabetes mellitus (gdm) is a common complication of pregnancy. multiple treatment regimens are currently used for the management of gdm. following failure of diet therapy, insulin, glyburide and metformin are all used in the treatment of gdm with the oral medications providing comparable outcomes with insulin but easier route of administration and schedule. the proposed work will evaluate the pharmacokinetics (pk) and pharmacodynamics (pd) of glyburide and metformin alone and in combination in order to lay the foundation in establishing dosage and response information that could be utilized in designing a phase iii randomized trial that will ultimately evaluate gdm treatment optimization.

Eligibility criteria:
inclusion criteria: gestational diabetes subject selection 1. pregnant women (singleton pregnancy) 2. gestational diabetes mellitus 3. able to give written informed consent 4. drug treatment is required for gdm 5. gestational age 20-32 weeks * gestational diabetes diagnosis must occur after 20 weeks and prior to 32 weeks gestation * randomization and treatment initiation must occur no later than 32 weeks gestation 6. willing to avoid ethanol 7. 18-45 years of age type 2 diabetes mellitus subject selection 1. able to give written informed consent 2. new diagnosis of type 2 diabetes mellitus 3. plan to receive metformin for treatment of type 2 diabetes mellitus 4. 18-45 years of age 5. female 6. negative pregnancy test 7. hemoglobin a1c \> 7% healthy pregnant women 1. able to give written informed consent 2. pregnant women (singleton) 3. normal 1-hour glucose tolerance test 4. 20-32 weeks gestation 5. 18-45 years of age neonates: all the infants of the pregnant women participating in this study will be included exclusion criteria: women with gdm and t2dm 1. women taking medications expected to interact with glyburide, metformin or alter blood glucose concentrations 2. serum creatinine \> 1.2 mg/dl 3. hematocrit \< 28% 4. allergy to glyburide, metformin or sulfa 5. significant hepatic disease 6. congestive heart failure or history of mi 7. moderate to severe pulmonary disease 8. adrenal or pituitary insufficiency healthy pregnant women 1. receiving any hypoglycemic agents 2. receiving corticosteroids 3. known kidney, liver, heart, pulmonary, adrenal or pituitary disease 4. hematocrit \< 28% neonates 1. infants that are not viable or too ill for blood sample collection will be included for clinical outcomes data collection, but will be excluded from other research activities. 2. infants \< 1.5 kg will be included for clinical outcomes data collection, but will be excluded from blood sample collection.

Keywords: pregnancy glyburide metformin pharmacokinetics pharmacodynamics
utility of squamous cell carcinoma antigen (scca) in psoriasis

Conditions: Psoriasis

Summary: squamous cell carcinoma antigen (scca) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. three studies have shown a correlation between blood levels of scca and the severity of psoriasis. clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation) but they suffer from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time. a readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

squamous cell carcinoma antigen (scca) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. three studies have shown a correlation between blood levels of scca and the severity of psoriasis. clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation). the pasi (psoriasis assessment severity index, minimum score 0, maximum 72) is the most widely used. it suffers from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time. this pasi score was "unavoidable" in the international clinical studies used to obtain marketing authorisation for medicines. the pga (physician global assessment) is simpler and less time-consuming, ranging from 0 to 4, but is not very discriminating. more recently, a "simplified psoriasis index" (prospi) health professional score has been developed, which correlates well with pasi for the severity component of psoriasis and with quality of life for the psychological component of the disease. it is less time-consuming to establish than pasi, but suffers like all clinical scores from a problem of inter- and intra-observer reproducibility. a readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patient with skin psoriasis (new and untreated or being treated, flare-up or stable, possibly bleached) * requiring a blood sample for disease or treatment monitoring exclusion criteria: * history of invasive mucosal squamous cell carcinoma, or squamous cell carcinoma of the skin with lymph node or visceral recurrence. * patient under guardianship or curatorship * opposition to participation in the study

Keywords: psoriasis squamous cell carcinoma antigen scca biomarker
non-invasive quantification of muscle and liver glutathione gsh-mrs

Conditions: Assay Muscle; Liver Glutathione in Healthy Human

Summary: glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. it participates also in the detoxification of electrophiles molecules of which paracetamol. it is synthesized in the liver during the postprandial phase, which establishes a stock that is mobilized for the other tissues (muscle)during the postabsorptive period. it is of common knowledge that the decrease in glutathione concentrations associated with ageing could be involved in the development of the degenerative pathologies linked to the old age. these changes could be reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous synthesis of gsh. the development of nutritional strategies aiming at an improvement of the status glutathione requires the determination of its concentration within tissues, where it is active. the quantification of tissue concentrations of glutathione by biochemical techniques requires tissue biopsies. such a method can be performed for the muscle, but liver biopsy is not feasible outside of a surgery. it is necessary to set up a non-invasive method to quantify muscle and liver glutathione.

the study will validate the detection and the quantification of glutathione in muscle and liver using 1h mrs. the accuracy of the method will be assessed from intra and inter-volunteer measurements. 1h mrs measurements will be performed with the magnetic resonance imaging (mri) 3 tesla system of the hospital, twice for each volunteer. prior to the measurements, volunteers will have a protein rich breakfast at home and a protein rich lunch at the clinical investigation center.

Eligibility criteria:
inclusion criteria: * - healthy volunteers, men or women, from 18 to 35 years old * having filled the questionnaire of compatibility in the mri and having no contraindication in the mri * having given their written, free and informed consent * affiliated with a social security system * 19 \< bmi \< 25 kg.m-2 exclusion criteria: * - age \ 35 ans * bmi \ 25 kg.m-2 * carrier of a pacemaker, cochlear implants, metallic implants or magnetic element (cf questionnaire of compatibility in the mri, appendix 3) * under treatment with repeated doses of paracetamol during the 2 weeks preceding the inclusion * under treatment in n-acetylcysteine during 2 weeks preceding the inclusion * regular sporttraining \> 3 hours / week * claustrophobia * difficulty of being immobile * pregnant women or women who are breast-feeding * incapacitated legal (private person of freedom or under guardianship) * people who cannot be followed and/or compliant in the requirements of the study for psychological, social, family or geographical reasons, * people already included in another clinical trial

Keywords: glutathione liver muscle proton magnetic resonance spectroscopy healthy human
a study of chinese congenital bicuspid aortic valve

Conditions: Bicuspid Aortic Valve (BAV)

Summary: pervious studies indicated that the prevalence of bicuspid aortic valve（bav） might be higher in china. there is a familial predisposition to the development of bav. the study analyzed epidemiological data on selected bav and established a bav cohort to observe disease progression and treatment outcomes.

there is no recognized comprehensive epidemiological data on congenital bav in china, although findings of bav is common in clinical practice. in the course of the venus-a registry clinical study, which was the first aortic valve replacement (tavr) trial in china, the investigators concluded about 40% of the final enrollment of bav patients. since then, an increasing number of scholars have figured out that the prevalence of bav may be much higher in china than abroad. this study was designed to investigate gene backgrounds, pathological progress, imaging characteristics of young health bav participants and their relationships in long-term follow-up. these findings may help to identify high risk individuals with specific gene expression or other features in clinical observation.

Eligibility criteria:
inclusion criteria: * the patients were aged 14-60 years; * definitive diagnosis of bav by imaging (echocardiography, aortic cta, cardiac magnetic resonance, etc.) * patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee. exclusion criteria: * poor patient compliance and inability to complete follow-up visits as required; * rheumatic heart valve disease, other organic valve disease. * hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics. * other circumstances that the researcher believes should be excluded.

Keywords: bicuspid aortic valve dilated ascending aorta aortic regurgitation aortic stenosis acoustic cardiography
the potential therapeutic effect of melatonin in gastro-esophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: gastro-esophageal reflux disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. many drugs used for the treatment of gerd such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. the aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.


Eligibility criteria:
inclusion criteria: * patient with gerd ranged from 42 to 56 years exclusion criteria: * patients with cardiac disease * patients with renal affection * patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis) * patients on the drugs known to affect the git motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks
paracetamol-tramadol and paracetamol-caffeine versus placebo in the emergency discharge treatment of renal colic

Conditions: Renal Colic

Summary: this is a prospective, randomized, single-blind study. patients included in the study after successful treatment of the acute attack were randomized upon discharge from the emergency department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.

this is a prospective, randomized, single-blind study. patients included in the study after successful treatment of the acute attack were randomized upon discharge from the emergency department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. different parameters are collected on a standard form prepared for all cases of renal colic included in our study. this sheet essentially contains: temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by vas, abdominal tenderness as well as the existence of giardano signs. additional examinations were not systematically carried out for all patients: ausp, ecbu, renal ultrasound, creatinemia and blood sugar. their realization depended on the clinical context. the use of imaging was done following the indications specified in the text of the consensus of the french society of emergency medicine (updated in 2008)

Eligibility criteria:
inclusion criteria: * -age \> 18 years old. * consent to participate in the study. * pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic. * pain score at discharge \< 30 (visual analog scale - vas or verbal numerical scale - vas from 0 to 100). exclusion criteria: * -inability to appreciate pain according to the vas. * pregnant or breastfeeding woman. * renal insufficiency with creatinine clearance \< 60 ml/min.

Keywords: renal colic paracetamol-tramadol paracetamol-cafeine placebo